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Firms Must Submit The Good, Bad, And Ugly Trial Data On Devices Under Clinical Trials Rule

Device firms will have to submit a lot more clinical trials outcomes data to the portal – including for products that have not been cleared, approved, or launched – based on a final rule recently issued by HHS. Even though sponsors can delay reporting two years, the rule expands the volume of reports that will find their way to the public-facing, clinical trials website and the change could have downsides, attorneys say.

Clinical Trial Regulation Policy and Regulation Medical Device

UK Regulator Wants To See Medtech Legislation Implemented Appropriately

Implementing the Medical Device Regulations in the EU is going to be a massive challenge. The UK’s head of devices stresses the need for collaboration, increased manpower and solutions around notified bodies.

Europe Policy and Regulation United Kingdom

Intuitive Surgical, Fosun Pair Up For Lung Cancer JV

Intuitive Surgical is setting up a China-based joint venture with its distribution partner Fosun Pharma that will develop robotic-assisted, catheter-based devices for diagnosing and treating lung cancer.

Cancer Surgery Diagnostic Imaging

Device Week – September 30, 2016

On this week's podcast, Medtech Insight journalists discuss Boston Scientific's acquisition of EndoChoice, a pivot by Circassia and some important FDA diabetes device approvals, including the first closed-loop artificial pancreas.

Medical Device Commercial Research and Development

Recent Tweets from Medtech Insight

Policy & Regulation

Set Alert for Policy & Regulation

Global Device-Makers Want India To Harmonize Standards

US medtech trade group AdvaMed is prodding the Indian government to harmonize what analysts have called “archaic” regulations governing medical devices with international standards, saying the result would be a win-win for both domestic and foreign companies.

India Regulation Market Access

US Health-Care Enforcement Focus Continues To Expand, Officials Say

Reimbursement efforts, individual liability and innovative corporate integrity agreements were among areas of focus at a recent Food and Drug Institute enforcement forum.

Medical Device Regulation Legal Issues

Latest From Policy and Regulation

Another Class I Recall For HeartWare's HVAD System

Medtronic announced FDA's high-risk designation of recalls from its new subsidiary’s products on Sept. 30. HeartWare products have been subject to a total of nine class 1 recalls since 2013.

Medical Device Product Recalls

Short-Term US Funding Bill Passes With $1.1bn In Emergency Zika Funds

Congress managed to settle its disputes over funding riders Sept. 28 and passed a relatively clean bill that contains $1.1bn in emergency Zika virus response funding, and will keep government agencies – including US FDA – running at current spending levels until Dec. 9.

United States Policy and Regulation

CDC Whistleblower Says Test Misses Too Many Zika Cases; US Special Counsel Calls For Review

The US CDC-promoted Trioplex Zika virus test that won an FDA emergency-use authorization in March is nearly 40% less sensitive than a rival CDC Zika test called Singleplex, a CDC microbiologist whistleblower told superiors in April. A review of his complaints by HHS and CDC did not substantiate that, and CDC demoted him. The US Special Counsel sent a letter to the White House this week asking for further review.

Policy Medical Device

More EU Audits, Post-Market Requirements: Tweeted Takeaways From ABHI Meeting

As the countdown to the EU Medical Device Regulation continues, delegates at the Association of British Healthcare Industries regulatory conference in London explored what to expect from the new rules. Here are some initial takeaways, tweeted by Medtech Insight from the meeting.

Europe Policy and Regulation

UK MHRA Presses For Leading Global Role Post-Brexit

The UK MHRA believes it has a valid and vital role to play on the global regulatory stage even after the UK leaves the EU.

United Kingdom Brexit

EU Regulation Recap: Chapter V Demonstrates Conformity Assessment Routes For Each Risk Class

What procedures will manufacturers need to follow to comply with the future medical device and IVD regulations, and when will a notified body need to be involved? A look at these issues as addressed in the fifth chapter of the pending regulatory documents.

Europe Policy and Regulation


Set Alert for Commercial

Sunshine Heart Changes Course Again: Pauses Neuromodulation To Focus On Aquadex

The company has switched from pursuing a counterpulsation technology to focusing on a fully implantable neuromodulation device, and is now directing its full attention to the recently acquired Aquadex FlexFlow ultrafiltration system for heart failure, all in a period of about three-to-four months.

Research and Development Clinical Trials Innovation

Latest From Commercial

KO’d By Allergy Failure, Circassia Looks To Respiratory Pipeline For Second Wind

Circassia is shifting its focus on its respiratory portfolio following the disappointing Phase III results of its cat allergy drug in June, which saw the company’s share price plummet by more than 60%.

Respiratory Companies

Boston Scientific Buys EndoChoice, Mulls De-FUSEing Potential Weakness

Boston Scientific is making a significant investment in its endoscopy portfolio as it strikes a $210m deal to buy colonoscopy specialist EndoChoice. The Natick, Massachusetts, group added that it will be “evaluating strategic options” for EndoChoice’s Fuse colonoscope.

Gastroenterology M and A

Reapplix Seals In More Funding For Diabetic Foot Ulcer Patch

Reapplix, an emerging autologous cell-based wound therapy specialist, has secured additional funding that will take the company through the next year before it gets “market-ready” to launch its diabetic foot ulcer treatment in the US and EU.

Diabetic Care Wound Management

Device Week – September 26, 2016

On this week's podcast, we discuss wound-care firm Advanced Medical Solutions, the latest developments for the US National Evaluation System for health Technology, and the debate over laboratory-development test regulations.

Medical Device United States

Five Charged In $20m Embezzlement At Hearing Aid Company

Three former executives at hearing aid company Starkey Laboratories, along with two outside conspirators, are facing federal fraud, conspiracy and money-laundering charges. The defendants reportedly stole more than $20m via a complicated web of sham companies between 2006 and 2015.

United States Commercial

GE Will Back Start-Ups Shooting For Improved Global Health

GE Healthcare has launched a health-care accelerator program to support global-health start-ups aiming to improve health-care quality and accessibility in developing economies.

StartUps and SMEs Financing

Clinical R&D

Set Alert for Clinical R&D

Abbott Gains US Approval For Pro Version Of Flash Glucose System

The FreeStyle Libre Pro is intended to provide health-care providers with an easy-to-read visual summary of a diabetic patient's glucose data. Abbott has also filed for approval with FDA for a consumer-targeted version of the device.

Research and Development Innovation Approvals

Latest From Research and Development

US FDA Approves First 'Artificial Pancreas' In Medtronic's MiniMed 670G

The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.

Approvals Diabetic Care

FDA Greenlights Historical Control In Trial Of Regentis' GelrinC Knee Repair Material

The pivotal clinical study will support a US pre-market approval to allow Regentis Biomaterials to market GelrinC for the repair of focal knee cartilage defects in the knee, the largest unmet need in orthopedic sports medicine, according to the company.

Orthopedics Clinical Trials

Medtronic Neurosurgery Software Gains US FDA Clearance

The application helps surgeons effectively place deep brain stimulation leads during cranial surgery.

Research and Development Medical Device

Glaukos' Micro-Bypass Stents Work As First-Line Glaucoma Therapy

Results of a 101-patient randomized clinical trial show that implantation of two iStent Trabecular Micro-Bypass stents is a viable initial treatment option, comparable to topical ocular hypotensive medications, in patients with newly diagnosed primary open-angle glaucoma.

Clinical Trials Research and Development

Medtronic Artificial Pancreas Trial Results Published

Medtronic’s Hybrid closed-loop system is safe and improves some key patient outcomes, according to results published in the Journal of the American Medical Association. The system is currently before FDA for review.

Research and Development Medical Device

FDA Issues How-To On Computational Modeling Reports

The document, which finalizes a 2014 draft guidance, details 15 key areas device-makers should include in device-submission reports on computer modeling and simulation.

United States Research and Development